Methods for diagnosing pathology of the liver in subject suspected of having such pathology by measuring the glycosylation of anti-gal IgG in various biological fluids of the subject.
Legal claims defining the scope of protection, as filed with the USPTO.
1. A method for detecting a liver disease in a subject suspected of having the liver pathology comprising: obtaining biological fluid from the subject; separating anti-gal IgG from said biological fluid using a separation agent; contacting said separated anti-gal IgG from said biological fluid with a fucose-binding lectin, IgG, and allowing said lectin to bind to said anti-gal IgG; quantifiably detecting lectin bound to said anti-gal IgG to obtain a detected bound lectin value; comparing the detected bound lectin value with a reference value for lectin binding on said anti-gal IgG from a comparable biological fluid of subjects without said liver disease, said detected bound lectin value relative to the reference value being indicative of the presence or absence of said liver disease, wherein a detected bound lectin value that deviates from said reference value to a statistically significant degree is indicative of the presence of said liver disease, or, comparing the detected bound lectin value with a reference value for lectin binding on said anti-gal IgG from a comparable biological fluid of subjects in which said liver disease is known to be present, said detected bound lectin value relative to the reference value being indicative of the presence or absence of said liver disease, wherein a detected bound lectin value that deviates from said reference value to a statistically significant degree is indicative of the absence of said liver disease.
2. The method according to claim 1 , wherein said liver disease is cirrhosis.
3. The method according to claim 1 , wherein said liver disease is liver fibrosis.
4. The method according to claim 1 , wherein said liver disease is hepatocellular carcinoma.
5. The method according to claim 1 , wherein said liver disease is hepatitis.
6. The method of claim 1 wherein the biological fluid is whole blood, serum, urine, saliva, tears, or mucous.
7. The method of claim 1 , wherein said separation agent comprises lectins, antibodies, or polypeptides by carbohydrate-recognition domains.
8. The method of claim 1 , wherein the lectin is coupled to a detectable moiety.
9. An assay for detecting a liver disease in a subject suspected of having the liver disease comprising: quantifiably detecting fucosylated anti-gal IgG from a biological fluid of said subject to provide a detected fucosylated anti-gal IgG value, wherein said detecting step utilizes an assay comprising a fucose-binding lectin, wherein a detected fucosylated anti-gal IgG value that deviates from a reference value for fucosylated anti-gal IgG from a comparable biological fluid of subjects without the liver disease is indicative of the presence of said liver disease, and wherein a detected fucosylated anti-gal IgG value that deviates from a reference value for fucosylated anti-gal IgG from a comparable biological fluid of subjects with the liver disease is indicative of the absence of said liver disease.
10. The assay according to claim 9 further comprising utilizing a separation agent to separate said fucosylated IgG from the biological fluid prior to quantifiably detecting the fucosylated anti-gal IgG.
11. The assay according to claim 10 , wherein said separation agent comprises lectins, antibodies, or polypeptides by carbohydrate-recognition domains.
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April 4, 2008
August 18, 2015
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